BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1970204 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01187
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    March 29, 2000
    Report Date
    December 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT THAT ONE OF HER LEADS HAD FRACTURED. THIS RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURES LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4244

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 4244| 1273| 4285